Suturing device

ABSTRACT

A suturing device for suturing a portion of biological tissue includes a needle attached to a suture, a needle holder that releasably holds the needle, and a needle driver adapted to be advanced and retracted substantially parallel to a longitudinal axis of the suturing device. A distal needle holder adapted to releasably hold the needle is positioned in a distal position relative to the portion of biological tissue and a distal end of the needle driver is positioned in a proximal position relative to the portion of biological tissue. The needle is positioned in either the proximal position or the distal position. The needle driver is moved longitudinally in a first direction along a path substantially parallel to the longitudinal axis such that the needle and suture pass through the portion of biological tissue, thereby forming a suture incision through which the suture passes. By repeating the above-described processes, a series of stitches is thereby formed.

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication, are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical devices.Specifically, the present invention relates to devices for facilitatingthe suturing of biological tissue.

2. Description of the Related Art

Sutures are frequently used to close various openings such as cuts,punctures, and incisions in various places in the human body. Because oftheir importance and frequent use, several types of sutures and devicesfor their implantation and extraction have been developed. Typically,suturing is performed by repeatedly passing a sharp suture needleattached to a length of suture material through portions of tissue to besutured together, thereby forming loops of suture material passingthrough the tissue. The free ends of the suture material are then tiedtogether to complete the suturing procedure.

There are however some circumstances under which it is not feasible touse conventional sutures and suturing methods to close an opening. It isoften difficult to reach some suture sites with existing suturingdevices because of the depth of the suture site within the humananatomy, the size of the suture site, and/or the restriction ofsurrounding organs and tissue. For example, where the tissue to besutured is within the patient's thorax (such as for an end-to-sideanastomosis in a cardiac bypass procedure), traditional methods ofsuturing are invasive and time consuming.

SUMMARY OF THE INVENTION

The present invention provides a device and method for suturing aportion of biological tissue.

One aspect of the present invention is a method of suturing a portion ofbiological tissue using a suturing device having a longitudinal axis, aneedle attached to a suture, a needle driver, and at least one needleholder. A distal needle holder adapted to releasably hold the needle ispositioned in a distal position relative to the portion of biologicaltissue and a distal end of the needle driver is positioned in a proximalposition relative to the portion of biological tissue. The needle ispositioned in either the proximal position or the distal position. Theneedle driver is moved longitudinally in a first direction along a pathsubstantially parallel to the longitudinal axis such that the needle andsuture pass through the portion of biological tissue, thereby forming asuture incision through which the suture passes. The above-describedprocesses are repeated to form a series of stitches.

Another aspect of the present invention is a method of suturing aportion of biological tissue. A needle is releasably held by a firstneedle holder, the needle being attached to a suture. The first needleholder is placed in a proximal position relative to a portion ofbiological tissue and a second needle holder is placed in a distalposition relative to the portion of biological tissue, so that theportion of biological tissue is between the first needle holder and thesecond needle holder. A force is applied to the needle by engaging theneedle with a needle driver and extending the needle driver in thedistal direction. This extension of the needle driver transfers theneedle from the first needle holder, through the portion of biologicaltissue between the first and second needle holders, to the second needleholder. The needle driver is disengaged from the needle and retracted inthe proximal direction away from the needle and the first and secondneedle holders. The first and second needle holders are laterallywithdrawn from the portion of biological tissue, and the positions ofthe first and second needle holders are exchanged, so that the firstneedle holder is in a distal position relative to the second needleholder and the needle.

Another aspect of the present invention is a suturing device forsuturing a portion of biological tissue. The suturing device comprises aneedle attached to a suture, a needle holder that releasably holds theneedle, and a needle driver adapted to be advanced and retractedsubstantially parallel to a longitudinal axis of the suturing device.

Another aspect of the present invention is a suturing device forsuturing a portion of biological tissue. The suturing device comprises aneedle attached to a suture, and a first needle holder adapted toreleasably hold the needle. The first needle holder is alternatelypositionable in a proximal position or a distal position relative to theportion of biological tissue. The suturing device further comprises asecond needle holder adapted to releasably hold the needle. The secondneedle holder is coupled to the first needle holder to be positionablein the proximal position when the first needle holder is in the distalposition, and in the distal position when the first needle holder is inthe proximal position. The suturing device further comprises a needledriver that transfers the needle from the needle holder in the proximalposition, through the portion of biological tissue between the first andsecond needle holders, to the needle holder in the distal position.

Another aspect of the present invention is a suturing device forsuturing a portion of biological tissue. The suturing device comprises aneedle attached to a suture, and a needle holder adapted to releasablyhold the needle. The needle holder is positioned distally relative tothe portion of biological tissue. The suturing device further comprisesa needle driver adapted to releasably hold the needle and to advance theneedle along a path substantially parallel to the longitudinal axis ofthe suturing device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a suturing device compatible with the preferredembodiment of the present invention, the suturing device comprising aproximal portion including a handle, and a distal portion including anelongated body and a suturing mechanism assembly.

FIG. 2 is an exploded view of a suturing mechanism assembly compatiblewith the preferred embodiment of the present invention.

FIG. 3A is a perspective view of the suturing mechanism assembly of FIG.1 in the first orientation.

FIG. 3B is a perspective view of the suturing mechanism assembly of FIG.1 in an intermediate orientation between the first orientation and thesecond orientation.

FIG. 3C is a perspective view of the suturing mechanism assembly of FIG.1 in the second orientation.

FIG. 4 is a perspective view of a needle, needle holder, and needledriver compatible with the preferred embodiment of the presentinvention.

FIG. 5A is a perspective view of the preferred embodiment of the presentinvention in the first orientation immediately prior to the creation ofa first stitch of the suture through a portion of biological tissue.

FIG. 5B is a perspective view of the preferred embodiment of the presentinvention after the needle driver pushes the needle and suture in thedistal direction substantially parallel to the longitudinal axis,thereby piercing a portion of biological tissue.

FIG. 5C is a perspective view of the preferred embodiment of the presentinvention after retracting the needle driver from the tissue.

FIG. 5D is a perspective view of the preferred embodiment of the presentinvention after withdrawing the suturing device away from the tissue.

FIG. 5E is a perspective view of the preferred embodiment of the presentinvention in the second orientation after creating a first stitch in thefirst orientation.

FIG. 5F is a perspective view of the preferred embodiment of the presentinvention in the second orientation immediately prior to the creation ofa second stitch of the suture through a portion of biological tissue.

FIG. 6A is a cross-sectional side view of the preferred embodiment of ahandle compatible with the present invention.

FIG. 6B is a view along the longitudinal axis in the proximal directionof the preferred embodiment of a handle compatible with the presentinvention.

FIG. 6C is a cross-sectional side view of the cylinders and actuatorrods of the preferred embodiment of a handle compatible with the presentinvention.

FIG. 6D is a cross-sectional top view of the preferred embodiment of ahandle compatible with the present invention.

FIG. 7A is a perspective view of an alternative embodiment of thepresent invention comprising a needle which is lockable to a needledriver.

FIG. 7B is a perspective view of the needle and needle driver of thealternative embodiment of FIG. 7A.

FIG. 8A is a perspective view of an alternative embodiment of thepresent invention comprising first and second needle holders rotatablyconnected to a swivel arm.

FIG. 8B is a back view of the swivel arm and locking pins of thealternative embodiment of FIG. 8A in a first orientation.

FIG. 8C is a back view of the swivel arm and locking pins of thealternative embodiment of FIG. 8A in a second orientation.

FIG. 9A is a perspective view of an alternative embodiment of thepresent invention comprising first and second needle holders rotatablyconnected to a pair of wheels.

FIG. 9B is a perspective view of the alternative embodiment of FIG. 9Ain an intermediate orientation between the first and secondorientations.

FIG. 9C is a perspective view of the alternative embodiment of FIG. 9Ain the second orientation.

FIG. 10A is a perspective view of an alternative embodiment of thepresent invention comprising a first needle holder slidably attached toan elongated body.

FIG. 10B is a cross-sectional view of two needle holders of thealternative embodiment of FIG. 10A with the first needle holder in itsmost-distal position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 illustrates a preferred embodiment of a suturing device 2 whichallows a physician to suture biological tissue at a variety of locationsand at a variety of depths within a body. For example, the suturingdevice 2 may be used to suture two layers or sections of tissue, such asan end-to-side anastomosis.

The suturing device 2 of the preferred embodiment illustrated in FIG. 1comprises a distal portion 4 and a proximal portion 6, each extendingalong a common longitudinal axis. The distal portion 4 of the suturingdevice 2 is the portion farthest from the physician or user (i.e.,closest to the suture site). The proximal portion 6 of the suturingdevice 2 is the portion closest to the user. In the description below,the distal direction is defined as the direction along the longitudinalaxis away from the user, and the proximal direction is defined as thedirection along the longitudinal axis toward the user.

The distal portion 4 of the suturing device 2 comprises an elongatedbody 10, and a suturing mechanism assembly 12. As illustrated in FIG. 2,the suturing mechanism assembly 12 comprises a first arm 20, a secondarm 30, a guide pin 40, a pivot pin 50, a cross piece 60, a first armactuator rod 70, a second arm actuator rod 80, a needle 90, a suture100, and a needle driver 110. The proximal portion 6 of the suturingdevice 2 comprises a handle 120, which is illustrated in more detail inFIGS. 5A-5D.

The elongated body 10 extends along the longitudinal axis from thehandle 120 to the suturing mechanism assembly 12 positioned near thedistal end of the distal portion 4 of the suturing device 2. To providea clear view of the suturing mechanism assembly 12 in FIGS. 2-5F, theelongated body 10 is shown with a cover portion removed, the coverportion including a guide hole for the suture 100 and the needle driver110. The elongated body 10 is rotatable about the longitudinal axis withrespect to the handle 120, thereby enabling the suturing mechanismassembly 12 to be rotationally manipulated with respect to the handle120 to position the suturing mechanism assembly 12 without′ rotating thehandle 120. Alternatively, only a distal portion of the elongated body10 and the suturing mechanism assembly 12 are rotatable about thelongitudinal axis with respect to the handle 120. In certainembodiments, the elongated body 10 is flexible thereby enabling thesuturing device 2 to be inserted along a curving puncture wound or bodylumen.

Referring to FIG. 2, the first arm 20 comprises a first arm body 21, afirst guide slot 22, a first notch 23, and a first needle holder 24 nearthe distal end of the first arm 20 with a first needle groove 26 and afirst suture release opening 28. Similarly, the second arm 30 comprisesa second arm body 31, a second guide slot 32, a second notch 33, and asecond needle holder 34 near the distal end of the second arm 30 with asecond needle groove 36 and a second suture release opening 38. Thefirst arm body 21 and the second arm body 31 are generally bar-shaped,each with a long axis 25, 35 and a rectangular cross-section. In thepreferred embodiment illustrated in FIG. 2, each arm body 21, 31 has acorresponding guide slot 22, 32 which is straight and substantiallyparallel to the long axis 25, 35 of the arm body 21, 31. In otherembodiments, the guide slots 22, 32 are curved, or include anglesdefined by multiple straight sections. Both the first arm body 21 andsecond arm body 31 are rotatably coupled near their proximal ends toopposite ends of the cross piece 60, which is rotatably coupled near itscenter to the pivot pin 50. Both the guide pin 40 and the pivot pin 50are fixedly connected to the elongated body 10. The first arm body 21and second arm body 31 are also both slidably coupled to the guide pin40 via the first guide slot 22 and the second guide slot 32,respectively.

The first arm actuator rod 70 is coupled to the first arm 20 near theend at which the first arm 20 is coupled to the cross piece 60, and thesecond arm actuator rod 80 is coupled to the second arm 30 near the endat which the second arm 30 is coupled to the cross piece 60. Both thearm actuator rods 70, 80 extend from the suturing mechanism assembly 12to the handle 120, and are movable longitudinally along the elongatedbody 10. As illustrated in FIGS. 3A-3C, the first arm 20 and second arm30 are movable relative to one another to a first orientation 200, asecond orientation 210, and a plurality of intermediate orientationsbetween the first orientation 200 and second orientation 210. With thesuturing device 2 in the first orientation 200, pushing the first armactuator rod 70 longitudinally in the distal direction and pulling thesecond arm actuator rod 80 longitudinally in the proximal directionrotates the cross piece 60 counter-clockwise about the pivot pin 50,until the second orientation 210 is reached. Conversely, with thesuturing device 2 in the second orientation 210, pulling the first armactuator rod 70 longitudinally in the proximal direction and pushing thesecond arm actuator rod 80 longitudinally in the distal directionrotates the cross piece 60 clockwise about the pivot pin 50, until thefirst orientation 200 is reached. In other embodiments, the rotation ofthe cross piece 60 is achieved by using only one actuator rod which ispushed and pulled accordingly to alternate between the first orientation200 and the second orientation 210.

In the first orientation 200 illustrated in FIG. 3A, the long axes 25,35 of the first arm body 21 and second arm body 31 are substantiallyparallel to one another, and the first needle groove 26 is substantiallycolinear to the second needle groove 36. In addition, the distal end ofthe first guide slot 22 is in proximity to the guide pin 40, and theproximal end of the second guide slot 32 is in proximity to the guidepin 40. The first needle holder 24 is in a proximal position relative tothe second needle holder 34 (i.e., the first needle holder 24 is closerto the handle 120 than is the second needle holder 34).

FIG. 3B illustrates an intermediate position of the first and secondarms 20, 30 of the preferred embodiment of the present invention. Byrotating the cross piece 60 counter-clockwise about the pivot pin 50,both the first arm 20 and second arm 30 are translated and rotatedrelative to the guide pin 40. As the cross piece 60 is rotatedcounter-clockwise, the first needle holder 24 is translated in thedistal direction and the second needle holder 34 is translated in theproximal direction. In addition, by virtue of the rotation of the firstand second arms 20, 30 about the guide pin 40, the first and secondneedle holders 24, 34 avoid contact with one another.

In FIG. 3C, the cross piece 60 is rotated further in thecounter-clockwise direction about the pivot pin 50, until the secondorientation 210 is reached. In the second orientation 210, the firstneedle holder 24 is in a distal position relative to the second needleholder 34. Furthermore, the long axes 25, 35 of the first arm body 21and second arm body 31 are again substantially parallel to one another,and the first needle groove 26 is again substantially colinear to thesecond needle groove 36. This colinearity of the first and second needlegrooves 26, 36 is due in part to the interlocking of the first notch 23and the second notch 33, to avoid the first arm body 21 from interferingwith the second needle holder 34.

The first and second needle grooves 26, 36 of the preferred embodimentillustrated in FIGS. 3A-3C are configured to be substantially colinearwith each other and parallel with the longitudinal axis of the elongatedbody 10 when the suturing device 2 is in either the first orientation200 or the second orientation 210. Alternatively, in other embodiments,the first and second needle grooves 26, 36 can be configured to besubstantially colinear with each other, but at an angle with respect tothe longitudinal axis of the elongated body 10. In still otherembodiments of the present invention, the first and second needlegrooves 26, 36 may be curved to form sections of a semi-circle or arc,such as to accommodate a curved needle 90 and a curved needle driver110.

FIG. 4 illustrates the first needle holder 24, needle 90, suture 100,and needle driver 110 of the preferred embodiment of the presentinvention. In the preferred embodiment, the second needle holder 34 issubstantially identical to the first needle holder 24. The needleholders 24, 34 are generally block-shaped, although in otherembodiments, the needle holders 24, 34 can be spherical, cylindrical, orany other suitable configuration. As illustrated in FIG. 4, the firstneedle holder 24 has a first needle groove 26 and a first suture releaseopening 28. The first needle groove 26 extends from the proximal surfaceto the distal surface of the first needle holder 24, and it has asubstantially circular cross-section. The first suture release opening28 also extends from the proximal surface to the distal surface of thefirst needle holder 24, and is cut into the opposite surface of thefirst needle holder 24 from the first arm body 21. The first suturerelease opening 28 is sufficiently wide to allow the suture 100 to bepulled laterally out of the first needle holder 24. In addition, thefirst needle holder 24 has a first spring slot 27 cut substantiallyperpendicularly to the first needle groove 26. The first spring slot 27contains a pair of first spring pins 29, 29′ which each have one endfixedly connected to the first needle holder 24, the other end free tomove within the first spring slot 27. Each of the first spring pins 29,29′ intersects the opposite sides of the first needle groove 26. Whenthe free ends of the first spring pins 29, 29′ are deflected outwardaway from the first needle groove 26, each first spring pin 29, 29′generates a restoring force in the inward direction toward the firstneedle groove 26. The second needle holder 34 similarly includes asecond needle groove 36, a second suture release opening 38, a secondspring slot 37 and a pair of second spring pins 39, 39′, all configuredsimilarly to their counterparts in the first needle holder 24.

The needle 90, which is substantially cylindrically symmetric, has apointed distal end 91, a relief 92, a generally cylindrical proximal end93, and an upper surface 94 as illustrated in FIG. 4. The pointed distalend 91 is configured to enable the needle 90 to be pushed along a distaldirection piercing biological tissue. The relief 92 is configured toengage the spring pins 29, 29′, 39, 39′ so that the needle 90 issecurely held in the needle holders 24, 34, but can be pushed out thedistal end of the needle grooves 26, 36 when sufficient force is appliedto the needle 90 in the distal direction. In the preferred embodiment,the suture 100 is fixedly attached near the proximal end 93 of theneedle 90. However, in other embodiments, the suture 100 can be fixedlyattached to other portions of the needle 90.

The needle driver 110 is a hollow cylinder with an inner diameter whichis larger than the outer diameter of the suture 100 and the outerdiameter of the proximal end 93 of the needle 90. The suture 100 extendsalong a length of the needle driver 110 through the center of the needledriver 110. The needle driver 110 is colinear with the first needlegroove 26 and the second needle groove 36, and is sufficiently rigid toapply a force to the needle 90 in the distal direction sufficient topass the needle 90 and the suture 100 through a portion of biologicaltissue between the needle holders 24, 34. For example, the needle driver110 is capable of applying to the needle 90 a force sufficient todisengage the needle 90 from the first spring pins 29, 29′, push theneedle 90 out the distal end of the first needle groove 26, through aportion of biological tissue between the first needle holder 24 andsecond needle holder 34, into the proximal end of the second needlegroove 36 of the second needle holder 34, where the needle is engaged bythe second spring pins 39, 39′. The needle driver 110 also has a suturerelease slit 112 which extends from the distal end of the needle driver110 along at least a portion of the needle driver 110 in the proximaldirection. The suture release slit 112 is sufficiently wide to allow thesuture 100 to be pulled out of the needle driver 100.

FIGS. 5A-5F illustrate one preferred embodiment of the present inventionduring the suturing of a portion of biological tissue 130. A physicianor medical practitioner first inserts the suturing device 2 through awound, such as an incision in a patient's muscle tissue, skin tissue,organ, blood vessel, etc. The physician then positions the suturingmechanism assembly 12 to suture a portion of biological tissue 130.

FIG. 5A illustrates the configuration immediately prior to the creationof a first stitch of the suture 100 through a portion of biologicaltissue 130. The suturing mechanism assembly 12 is in the firstorientation 200 with the first needle holder 24 in a proximal positionrelative to the tissue 130, and the second needle holder 34 in a distalposition relative to the tissue 130. The needle 90 is held in the firstneedle groove 26 of the first needle holder 24 by the first spring pins29, 29′ (not shown). The needle driver 110 is positioned so that itsdistal end is engaged with the proximal end 93 and upper surface 94 ofthe needle 90, and the suture 100 extends from the proximal end 93 ofthe needle 90 through a length of the needle driver 110.

The needle driver 110 is then extended distally, thereby applying aforce to the needle 90 and moving it distally towards the second needleholder 34 in the longitudinal direction. The needle 90 is thus pusheddistally away from the first spring pins 29, 29′, out the distal end ofthe first needle groove 26 of the first needle holder 24, piercing thetissue 130, and into the proximal end of the second needle groove 36 ofthe second needle holder 34, where it is secured by the second springpins 39, 39′ (not shown). As shown in FIG. 5B, after such driving of theneedle 90, the suture 100 and the needle driver 110 extend from theneedle 90 in the second needle groove 36 of the second needle holder 34,through the tissue 130, and through the first needle groove 26 of thefirst needle holder 24, thereby forming a first suture incision 132.

The needle driver 110 is then retracted in the proximal direction awayfrom the needle 90 held in the second needle holder 34. As shown in FIG.5C, once retracted, the needle driver 110 no longer passes through thefirst needle holder 24, the tissue 130, or the second needle holder 34.However, the suture 100 remains attached to the proximal end 93 of theneedle 90, passing from the second needle holder 34, through the tissue130, and through the first needle groove 26 of the first needle holder24.

The suturing mechanism assembly 12 is then withdrawn from the firstsuture incision 132 where the suture 100 passes through the tissue 130.As shown in FIG. 5D, withdrawal of the suturing mechanism assembly 12from the tissue 130 pulls the suture 100 out of the first needle holder24 through the first suture release opening 28 and out of the needledriver 110 through the suture release slit 112. Because the suture 100is attached to the needle 90 held in the second needle holder 34, thewithdrawal of the suturing mechanism assembly 12 from the tissue 130also pulls an additional length of suture 100 out of the needle driver110. This additional length of suture 100 provides sufficient slack inthe suture 100 for the movement of the suturing mechanism assembly 12from the first orientation 200 to the second orientation 210. Thesuturing mechanism assembly 12 is withdrawn from the tissue 130 asufficient distance to permit unobstructed movement of the arms 20, 30between the first orientation 200 and the second orientation 210.

In preparation for additional suturing, the suturing mechanism assembly12 is moved to the second orientation 210 from the first orientation200, thereby reversing the relative positions of the first needle holder24 and the second needle holder 34. FIG. 5E illustrates the secondorientation 210 of the suturing mechanism assembly 12. In the secondorientation 210, the second needle holder 34 and the needle 90 arepositioned proximally to the first needle holder 24. The suturingmechanism assembly 12 can then be placed in proximity to another portionof the tissue 130 and the needle driver 110 can be extended to engagethe needle 90, as illustrated in FIG. 5F. In this way, the suturingmechanism assembly 12 is then configured to begin the creation of asecond stitch of the suture 100 through a second suture incision 134 inthe tissue 130 in a similar manner. It will be apparent to those ofskill in the art that a second suture incision 134 may be made in anysuitable location relative to the first suture incision 132. After thephysician has placed one or more stitches in the biological tissue 130,the physician may withdraw the suturing device 2 from the biologicaltissue 130. The physician may then tie a knot with the ends of thesuture 100 or slide a clip down the suture 100 to tighten and secure thesuture 100 on the wound.

The suturing device 2 of the preferred embodiment has particularusefulness in the field of end-to-side anastomosis, such as practicedduring minimally invasive coronary artery bypass graft (CABG)procedures. In a minimally invasive CABG procedure, a series of severalsmall ports are made in the chest wall to gain access to the thoraciccavity, typically through the third or fourth intercostal space in themidaxillary or midclavicular line. These ports provide access forvarious surgical tools to the area of the coronary artery bypass, suchas an endoscope, irrigation and suction tools, and cutting and suturingdevices. Development of devices and methods useful for assisting withsuch minimally invasive CABG procedures is currently an area of muchactivity. (See, e.g., two pending U.S. patent applications by Nobles,U.S. patent application Ser. No. 09/121,443: “Direct Access AorticOcclusion Device”, filed Jul. 23, 1998, and U.S. patent application Ser.No. 09/193,977: “Device and Method for Partially Occluding Blood VesselsUsing Flow-Through Balloon,” filed Nov. 18, 1998, both of which areincorporated by reference herein.)

The CABG procedure includes end-to-side anastomosis, in which the endsof a venous or arterial graft are sutured to surgical openings made inthe aortic root, and in the coronary artery at a position distal alongthe direction of blood flow to the coronary obstruction. The compactsize and suturing method of the present invention enable successfulend-to-side anastomosis in this challenging environment. During atypical procedure using the preferred embodiment of the presentinvention, one end of the venous graft is positioned near acorresponding opening in the aortic root. The suturing mechanismassembly 12 is then placed so that the first needle holder 24 is placedin a proximal position relative to a portion of the tissue of the oneend of the graft and/or the surgical opening in the aortic root, and thesecond needle holder 34 is placed in a distal position relative to thesame portion of tissue. A force is applied to the needle 90 by engagingthe needle 90 with the needle driver 110, and extending the needledriver 110 in the distal direction. This extension of the needle driver110 transfers the needle 90 from the first needle holder 24, through theportion of tissue between the first and second needle holders 24, 34, tothe second needle holder 34. The needle driver 110 is disengaged fromthe needle 90 and retracted in the proximal direction away from theneedle 90 and the first and second needle holders 24, 34. The first andsecond needle holders 24, 34 are laterally withdrawn from the portion oftissue, and the positions of the first and second needle holders 24, 34are exchanged so that the first needle holder 24 is in a distal positionrelative to the second needle holder 34 and the needle 90. By placing adifferent portion of tissue between the first and second needle holders24, 34, and repeating the above-described process, a series ofcontinuous suture rows is formed thereby connecting the perimeter of theend of the venous graft to the perimeter of the opening in the aorticroot. Alternatively, a series of interrupted suture rows may be formedby tying off the suture after forming each suture incision. A similarprocedure is performed to connect the other end of the graft to theperimeter of a corresponding surgical opening in the coronary artery ata position distal to the obstruction along the direction of blood flow.

The handle 120 provides the physician or medical practitioner control ofall the degrees of movement of the various components of the suturingdevice 2. FIGS. 6A-6D illustrate a preferred embodiment of the handle120 of the present invention. The handle 120 comprises a housing 310, anarm actuator assembly 320, a rotator 340, and a needle driver actuatorassembly 350. Persons skilled in the art are able to provide alternativeembodiments of the handle 120 which sufficiently provide control of thevarious degrees of movement used to practice the present invention.

The housing 310 of the preferred embodiment of the present inventioncontains the various components of the handle 120 in a pistol-likeconfiguration. Such a configuration allows the physician to operate thesuturing device 2 primarily with one hand.

The arm actuator assembly 320 of the preferred embodiment of the presentinvention comprises a thumbwheel 321, a thumbwheel axis 322, a firstlinear actuator rod 323, a second linear actuator rod 324, a first innercylinder 325, a first outer cylinder 326, a second inner cylinder 327,and a second outer cylinder 328. The thumbwheel 321 is a substantiallycircular disk that is rotatable about the thumbwheel axis 322 which ismounted through the center of the thumbwheel 321 and supported byrecesses in the housing 310. The proximal end of the first linearactuator rod 323 is rotatably attached to the thumbwheel 321 near theperimeter of the thumbwheel 321. Similarly, the proximal end of thesecond linear actuator rod 324 is rotatably attached to the thumbwheel321 near the perimeter of the thumbwheel 321 at a position 180 degreesfrom the attachment of the first linear actuator rod 323. The distal endof the first linear actuator rod 323 is fixedly attached to the firstinner cylinder 325, and the distal end of the second linear actuator rod323 is fixedly attached to the first outer cylinder 326.

The first inner cylinder 325 is positioned within, and coaxially to, thefirst outer cylinder 326. A first inner tab 329 on the first innercylinder 325 are slidably engaged with a first outer slot 330 in thefirst outer cylinder 326, thereby allowing the first inner cylinder 325to slide longitudinally without rotating in relation to the first outercylinder 327. Similarly, a pair of first outer tabs 331, 331′ on thefirst outer cylinder 326 are slidably engaged with a pair of firsthousing slots 332, 332′ in the housing 310, thereby allowing the firstouter cylinder 326 to slide longitudinally without rotating in relationto the housing 310.

The second inner cylinder 327 is positioned within, and coaxially to,the second outer cylinder 328. A pair of second inner tabs 333, 333′ onthe second inner cylinder 327 are slidably engaged with a pair of secondouter slots 334, 334′ in the second outer cylinder 328, thereby allowingthe second inner cylinder 327 to slide longitudinally without rotatingin relation to the second outer cylinder 328. Similarly, a pair ofsecond outer tabs 335, 335′ on the second outer cylinder 328 areslidably engaged with a pair of second rotator slots 336, 336′ in arotator 340, thereby allowing the second outer cylinder 328 to slidelongitudinally without rotating in relation to the rotator 340. Therotator 340 is rotatably connected to the housing 310.

Both the first inner cylinder 325 and the second inner cylinder 327 havesubstantially the same outer diameters, and are rotatably engaged withone another in a colinear orientation. Similarly, both the first outercylinder 326 and the second outer cylinder 328 have substantially thesame outer diameters, and are rotatably engaged with one another in acolinear orientation. In addition, the proximal end of the first armactuator rod 70 is fixedly attached to the second outer cylinder 328,and the proximal end of the second arm actuator rod 80 is fixedlyattached to the second inner cylinder 327.

This configuration of coupled cylinders and actuator rods provides boththe linear actuation used to operate the arms 20, 30 of the suturingmechanism assembly 12, and the rotation of the suturing mechanismassembly 12 in relation to the handle 120. By rotating the thumbwheel321, the first linear actuator rod 323 and the second linear actuatorrod 324 are longitudinally translated relative to one another. Thislongitudinal translation of the linear actuator rods 323, 324 results ina longitudinal translation of the inner cylinders 325, 327 relative tothe outer cylinders 326, 328, and a longitudinal translation of thefirst arm actuator rod 70 with respect to the second arm actuator rod80. As explained above, this motion of the arm actuator rods 70, 80results in a transition of the suturing mechanism assembly 12 betweenthe first orientation 200 and the second orientation 210.

Furthermore, by rotating the rotator 240 in relation to the housing 310,the second inner cylinder 327, the second outer cylinder 328, and thearm actuator rods 70, 80 are rotated in relation to the handle 120. Inaddition, the elongated body 10 is fixedly attached to the rotator 240,so this rotation results in a rotation of the suturing mechanismassembly 12, which can be used to orient the suturing mechanism assembly12 to reach various portions of the tissue to be sutured.

The needle driver actuator assembly 350 comprises a trigger 351, atrigger pivot pin 352, a trigger spring 353, and a driver actuator 354.The trigger 351 is generally “racetrack”-shaped with an actuator arm 355extending into the housing 310. The actuator arm 355 is coupled to thedriver actuator 354 and to the trigger spring 353 which is attached tothe actuator arm 355 and to the housing 310. The driver actuator 354 iscoupled to the needle driver 110 so that a longitudinal translation ofthe driver actuator 354 results in a longitudinal translation of theneedle driver 110, and so that the needle driver 110 maintains itsorientation in relation to the rest of the suturing mechanism assembly12 when the suturing mechanism assembly 12 is rotated with respect tothe handle 120.

The trigger 351 is rotatable and pivots about the trigger pivot pin 352which is mounted through the trigger 351 and supported by recesses inthe housing 310. The driver actuator 354 slidably passes through acoaxial hole through the first inner cylinder 325 and the second innercylinder 327. By compressing the trigger 351 against the housing 310,the actuator arm 355 pivots about the trigger pivot pin 352, therebystretching the trigger spring 353, and extending the driver actuator 354longitudinally in the distal direction. In this way, the physician isable to press a suture 100 through tissue 130 positioned between thefirst needle holder 24 and the second needle holder 34. The triggerspring 353 provides a restoring force which returns the trigger 351,driver actuator 354, and needle driver 110 to their retracted positions.

In another embodiment, illustrated in FIGS. 7A and 7B, only one needleholder 434 is used by the suturing device 402. This embodiment includesa locking pin 495 extending perpendicularly from the cylindricalproximal end 493 of the needle 490, and a needle driver 410 with alocking slot 413 and the capability of being rotated about itslongitudinal axis. With the locking pin 495 engaged with the lockingslot 413 of the needle driver 410, as illustrated in FIG. 7B, the needle490 is releasably attached to the needle driver 410. Upon driving theneedle 490 in the longitudinal direction through the tissue 130, theneedle 490 is held by the needle holder 434 in a distal positionrelative to the tissue 130. The needle driver 410 is then rotatedrelative to the needle 490 to unlock the locking pin 495 from thelocking slot 413, and the needle driver 410 is then retracted todisengage it from the needle 490. After withdrawing the suturingmechanism assembly 412 from the tissue 130, thereby pulling a sufficientlength of suture 100 to provide sufficient slack, the needle driver 410then extends and re-attaches to the needle 490 by re-engaging thelocking pin 495 with the locking slot 413. The needle driver 410 thenretracts from the needle holder 434, pulling the needle 490 from theneedle holder 434. The suturing mechanism assembly 412 is then ready tocreate a second stitch of the suture 100 through another portion oftissue 130.

Alternatively, the needle 490 and the attached suture 100 are firstreleasably held by the needle holder 434 in a distal position relativeto the tissue 130, with the needle driver 410 in a proximal positionrelative to the tissue 130. Upon driving the needle driver 410 in thelongitudinal direction through the tissue 130, the needle driver 410engages the needle 490 being held by the needle holder 434. The needledriver 410 is then rotated relative to the needle 490 to lock thelocking pin 495 with the locking slot 413, and the needle driver 410 isthen retracted to withdraw the needle in the proximal direction from theneedle holder 434. In this way, the suturing mechanism assembly 412 isable to create a stitch that starts on the distal side of the tissue 130and finishes on the proximal side of the tissue 130. The physician ormedical practitioner is therefore able to choose which direction theneedle 490 and suture 100 pass through the tissue 130, instead of onlyhaving the option of pushing the needle 490 in the distal direction. Bypulling the suture 100 from the distal side of the tissue 130, thenpushing the suture 100 from the proximal side of the tissue 130 inalternating fashion, a desirable configuration of stitches may be formedin which the suture 100 only crosses the plane of the tissue 130 bypassing through the tissue 130.

In another embodiment, illustrated in FIGS. 8A-8C, a suturing device 502includes first and second needle holders 524, 534 rotatably connected toa swivel arm 520 which rotates in relation to the elongated body 510about a swivel shaft 522 to alternate between the first orientation 200and the second orientation 210. In the embodiment illustrated in FIGS.8A-8C, the swivel shaft 522 extends from the center of the swivel arm520, but in other embodiments, the swivel shaft 522 can be located atother positions along the swivel arm 520.

Fixedly attached to a distal portion of the elongated body 510 are aproximal locking pin 512 and a distal locking pin 514. The swivel arm520 comprises an internal pulley system 530 and four grooves 523, 525,526, 528 molded or otherwise shaped into a back portion of the swivelarm 520 facing the elongated body 510. The first and fourth grooves 523,526 are configured to receive the proximal locking pin 512. The secondand third grooves 528, 525 are configured to receive the distal lockingpin 514. In FIG. 8B, the swivel arm 520 is in the first orientation 200in which the proximal locking pin 512 is in the second groove 528, andthe distal locking pin 514 is in the fourth groove 526. In FIG. 8C, theswivel arm 520 is in the second orientation 210, in which the proximallocking pin 512 is in the first groove 523, and the distal locking pin514 is in the third groove 525.

The configuration of the second and fourth grooves 528, 526 and thelocking pins 512, 514 prevents the swivel arm 520 from rotatingcounter-clockwise while the swivel arm 520 is in the first orientation200 as illustrated in FIG. 8B. Similarly, the configuration of the firstand third grooves 523, 525 and the locking pins 512, 514 prevent theswivel arm 520 from rotating clockwise while the swivel arm 520 is inthe second orientation 210 as illustrated in FIG. 8C. Thus, the proximaland distal locking pins 512, 514 prevent the swivel arm 520 fromrotating by more than 180 degrees in either a clockwise or acounter-clockwise direction. In alternative embodiments, othermechanisms or configurations of the suturing device 502 can be used toappropriately limit the rotation of the swivel arm 520 about the swivelshaft 522.

Alternatively, other embodiments of the suturing device 502 provide morethan two positions. For example, the suturing device 502 may providethree or four positions. Likewise, other embodiments may providerotations of less than 180 degrees or more than 180 degrees. Inembodiments of the suturing device 502 with more than two positionsand/or with rotations of more than or less than 180 degrees, a set oflocking pins, such as the proximal and distal locking pins 512, 514 areconfigured to limit the movement of the swivel arm 520 accordingly. Forexample, one embodiment of the suturing device 502 may be configured torotate between clockwise and/or counter-clockwise by 90 degrees byutilizing a set of locking pins to limit the rotation of the swivel arm520 to clockwise and/or counter-clockwise by 90 degrees. Persons skilledin the art can recognize appropriate configurations of locking pins tolimit the rotation of the swivel arm 520 compatible with the presentinvention.

The internal pulley system 530 of the swivel arm 520 comprises a seriesof wheels and flexible bands which have the effect of rotating the firstand second needle holders 524, 534 as the swivel arm 520 is rotatedabout the swivel shaft 522. The internal pulley system 530 is configuredto maintain the relative directional orientation of the first needlegroove 526 relative to the second needle groove 536 in the firstorientation 200 and second orientation 210.

In another alternative embodiment of the present invention, illustratedin FIGS. 9A-9C, both a first arm 620 and second arm 630 are rotatablyattached to a first wheel 640 and a second wheel 650. As illustrated inFIG. 9A, in the first orientation 200, a first needle groove 626 of afirst needle holder 624 of the first arm 620 is substantially colinearwith a second needle groove 636 of a second needle holder 634 of thesecond arm 630, with the first needle holder 624 in a proximal positionrelative to the second needle holder 634. To place the arms 620, 630 inthe second orientation 210, the wheels 640, 650 are rotated clockwise,as illustrated in FIG. 9B. The second orientation 210 is reached oncethe wheels 640, 650 have rotated 180 degrees, as illustrated in FIG. 9C,thereby placing the second needle holder 634 of the second arm 630substantially colinear with the first needle holder 624 of the first arm620, with the second needle holder 634 in a proximal position relativeto the first needle holder 624.

In another alternative embodiment of the present invention, illustratedin FIGS. 10A and 10B, a suturing device 702 includes a first needleholder 724 which is slidably attached to an elongated body 710, via anaperture 711, a first support 720, and a biasing spring 721. A secondneedle holder 734 is fixedly attached to a distal portion of theelongated body 710 via a second support 730. The suture release openings728, 738 are sufficiently wide to allow a suture 100 to slide laterallyout of the needle holders 724, 734, but are sufficiently narrow toprevent the needle 790 from sliding laterally out of the needle holders724, 734.

The first needle holder 724 is attached to the first support 720, whichis partially received within the elongated body 710 through the aperture711. The biasing spring 721 is operatively received within the elongatedbody 710 and provides a proximal biasing force on the first support 720.Using a linear actuator in the handle (not shown), the physician cantranslate the first support 720 in the distal direction, therebybringing the first and second needle holders 724, 734 together.

FIG. 10B is a cross-sectional view of the two needle holders 724, 734 ofFIG. 9A, with the first needle holder 724 in its most-distal position.In FIG. 10B, the needle 790 comprises a proximal head 791 with a slopedsurface 792, which is sloped radially outward, and a locking surface793. The proximal head 791 of the needle 790 is attached to a suture100, and has a diameter approximately equal to or less than the diameterof a distal end 727 of the first needle groove 726. The second needlegroove 736 is configured to hold the needle 790 such that the proximalhead 791 of the needle 790 remains external to the second needle holder734.

As shown in FIG. 10B, the distal portion 727 of the first needle groove726 is sloped radially inward. The distal portion 727 of the firstneedle groove 726 is also made of a resilient material, which can expandfrom its original shape and contract back to its original shape. Thedistal portion 727 of the first needle groove 726 expands when the firstneedle holder 724 is advanced in the distal direction by the needledriver (not shown), thereby freeing the needle 790 from the first needleholder 724. The distal portion 727 of the first needle groove 726 alsoexpands when it comes in contact with the sloped surface 792 of theproximal head 791 of the needle 790, and contracts when the proximalhead 791 is completely within the first needle groove 726, therebyrecapturing the needle 790 from the second needle holder 734. Oncerecaptured, the needle 790 is retracted from the second needle holder734 as the first needle holder 724 is retracted in the proximaldirection away from the second needle holder 734.

To use the suturing device 702 illustrated by FIGS. 10A and 10B, thephysician first positions the biological tissue to be sutured (notshown) between the first and second needle holders 724, 734. Thephysician then actuates the needle driver to push the needle 790 in thelongitudinal direction through the first needle groove 726. The distalportion 727 of the first needle groove 726 expands outward as the needle790 is pushed distally out of the first needle groove 726. The needledriver 740 continues pushing the needle 790 longitudinally until theneedle 790 pierces the biological tissue and enters the second needlegroove 736 of the second needle holder 734. The needle driver 740 isthen retracted in the proximal direction until it is clear of the firstneedle holder 724.

The physician then withdraws the suturing device 702 laterally away fromthe edge of the biological tissue. The physician then advances the firstneedle holder 724 distally until the distal portion 727 of the firstneedle groove 726 captures the proximal head 791 of the needle 790. Thefirst needle holder 724 is then retracted in the proximal direction,pulling the needle 790 in the proximal direction away from the secondneedle holder 734. Once the first needle holder 724 is fully retracted,the physician may then position another section of biological tissue tobe sutured between the needle holders 724, 734.

While embodiments and applications of this invention have been shown anddescribed, it will be apparent to those skilled in the art that variousmodifications are possible without departing from the scope of theinvention. It is, therefore, to be understood that within the scope ofthe appended claims, this invention may be practiced otherwise than asspecifically described.

1. A method of suturing a portion of biological tissue using a suturingdevice having a longitudinal axis, a needle attached to a suture, aneedle driver, and at least one needle holder, the method comprising:(a) positioning a distal needle holder in a distal position relative tothe portion of biological tissue, the distal needle holder adapted toreleasably hold the needle, and positioning a distal end of the needledriver in a proximal position relative to the portion of biologicaltissue; (b) positioning the needle in either the proximal position orthe distal position; (c) moving the needle driver longitudinally in afirst direction along a path substantially parallel to the longitudinalaxis such that the needle and suture pass through the portion ofbiological tissue, thereby forming a suture incision through which thesuture passes; and (d) repeating (a)-(c) to form a series of stitches.2. The method of claim 1 further comprising moving the needle driverlongitudinally in a second direction substantially opposite to the firstdirection along the path substantially parallel to the longitudinalaxis.
 3. The method of claim 1, wherein the needle is positioned in aproximal position relative to the portion of biological tissue byreleasably holding the needle in a proximal needle holder positioned ina proximal position relative to the portion of biological tissue.
 4. Themethod of claim 3, wherein moving the needle driver longitudinally inthe first direction advances the needle from the proximal needle holderto the distal needle holder.
 5. The method of claim 3, wherein thedistal needle holder is positioned in the distal position relative tothe portion of biological tissue by placing the proximal needle holderin the distal position.
 6. The method of claim 3, wherein the needle ispositioned in the proximal position relative to the portion ofbiological tissue by releasably holding the needle with the distalneedle holder positioned in the distal position relative to the portionof biological tissue and translating the distal needle holder to theproximal position.
 7. The method of claim 3, wherein the needle ispositioned in the proximal position relative to the portion ofbiological tissue by translating the proximal needle holder distallyalong a path substantially parallel to the longitudinal axis to engagethe needle being releasably held by the distal needle holder, releasablyholding the needle with the proximal needle driver, releasing the needlefrom the distal needle holder, and translating the proximal needleholder and needle proximally along a path substantially parallel to thelongitudinal axis to the proximal position.
 8. The method of claim 1,wherein the needle is positioned in a proximal position relative to theportion of biological tissue by releasably holding the needle near adistal end of the needle driver.
 9. The method of claim 8, whereinmoving the needle driver longitudinally in the first direction resultsin the needle being releasably held by the distal needle holder.
 10. Themethod of claim 9, wherein the method further comprises releasing theneedle from the needle driver after the needle is releasably held by thedistal needle holder.
 11. The method of claim 10, wherein the needle ispositioned in the proximal position relative to the portion ofbiological tissue by extending the needle driver longitudinally,releasably holding the needle near the distal end of the needle driver,releasing the needle from the distal needle holder, and retracting theneedle driver and the needle to the proximal position.
 12. The method ofclaim 2, wherein the needle is positioned in a distal position relativeto the portion of biological tissue by releasably holding the needlewith the distal needle holder.
 13. The method of claim 12, whereinmoving the needle driver longitudinally in the first direction advancesthe needle from the distal position to the proximal position.
 14. Themethod of claim 1, wherein the needle is releasably held by the needledriver after moving the needle driver longitudinally in the seconddirection.
 15. The method of claim 14, wherein the needle is positionedin the distal position relative to the portion of biological tissue byextending the needle driver longitudinally, releasably holding theneedle with the distal needle holder, releasing the needle from theneedle driver, and retracting the needle driver to the proximalposition.
 16. A method for suturing a portion of biological tissue, themethod comprising: releasably holding a needle with a first needleholder, the needle being attached to a suture; placing the first needleholder in a proximal position relative to a portion of biological tissueand placing a second needle holder in a distal position relative to theportion of biological tissue, so that the portion of biological tissuelOis between the first needle holder and the second needle holder;applying a force to the needle by engaging the needle with a needledriver and extending the needle driver in the distal direction, therebytransferring the needle from the first needle holder, through theportion of biological tissue between the first and second needleholders, to the second needle holder; disengaging the needle driver fromthe needle and retracting the needle driver in the proximal directionaway from the needle and the first and second needle holders; laterallywithdrawing the first and second needle holders from the portion ofbiological tissue; exchanging positions of the first and second needleholders so that the first needle holder is in a distal position relativeto the second needle holder and the needle. 17.-22. (canceled)